BERKELEY HEIGHTS, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Genta Incorporated announced the presentation of scientific data that may greatly expand the use of the Company’s lead anti-cancer drug, Genasense(R) (oblimersen sodium) injection. The new preclinical results showed that intermittent administration of Genasense by bolus injection significantly increased the anticancer activity of erlotinib (Tarceva(R); OSI Pharmaceuticals), including cancers that were not sensitive to erlotinib. Results of these studies were presented today at the annual AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, PA.
Genasense inhibits a key chemotherapy resistance factor. Prior studies of Genasense combined with chemotherapy focused on regimens that were administered every three weeks. However, many of the Genasense dosing schedules that demonstrated increased activity were difficult to employ in practice, especially when combined with therapies that were given daily or several times per week, such as interferon, rituximab, erlotinib, and radiation.
Using murine models of human non small cell lung cancer, investigators evaluated Genasense given both continuously as well as every second, third or fourth day. Intermittent doses of Genasense demonstrated significant activity when given alone in this model, whereas erlotinib alone exhibited little activity. However, the combination of Genasense plus erlotinib was superior to either agent alone. Moreover, the optimal schedule of Genasense used with daily erlotinib was shown to be discontinuous dosing every three days, which yielded 90% survival at 100 days.
“These preliminary studies may greatly extend the utility of Genasense,” commented Dr. Bob Brown, Vice-President for Research and Technology at Genta. “We and others have shown that Genasense enhanced the preclinical activity of many drugs that are administered more frequently than every three weeks. The new findings may enable practical applications of Genasense with a variety of multi-dose anticancer therapies, such as temozolomide and interferon in melanoma, rituximab in lymphoma, tyrosine kinase inhibitors in lung cancer, and radiation therapy.”
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense to evaluate its potential to treat various forms of cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company’s research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection, the Company’s lead compound from its oligonucleotide program, is currently undergoing late-stage, Phase 3 clinical testing. In 2005, the Company initiated a “rolling” New Drug Application to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide in patients with relapsed or refractory chronic lymphocytic leukemia. The Company anticipates that the NDA will be completed by year-end 2005. The Company has also indicated its intention to submit by year-end 2005 a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the use of Genasense plus dacarbazine in patients with advanced melanoma. The leading drug in Genta’s small molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
This press release contains forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company’s Annual Report/Form 10-K for 2004.
Genta Incorporated
CONTACT: media, TS Communications Group, LLC, info@genta.com, or908-286-3980, or investors, Greg Tiberend of Richard Lewis Communications,Inc., 212-827-0020
Web site: http://www.genta.com//
